**Option for Permanent Employment or 2 year contract
GxP Systems provides world-class engineering consulting and project management services to multinational clients in regulated industries.
We are currently seeking a Validation Manager to coordinate the development and execution of a validation program in compliance with all applicable regulatory requirements. A minimum of 7 years of experience required in a cGMP regulated environment with at least 3 years working in a validation lead role.
The Validation Manager shall be responsible for developing validation as well as integrated commissioning and qualification plans and reviewing and approving commissioning and validation documents in accordance with current GMPs. This individual will determine and develop approaches to resolve complex validation issues
The Validation Manager must possess excellent verbal and written communication skills and the ability to communicate validation requirements, timelines, and resource needs to management. The Validation Manager will work closely with the project team members such as Engineering, and the Quality Assurance Group, to incorporate the appropriate elements of quality and production into validation strategies. This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved. Good communication and motivation ability is required.
· Lead the validation of project equipment, utilities, processes and software in compliance with client’s policies, FDA, European cGMP and GAMP standards.
· Update of the Validation Master Plan
· Generation/maintenance of Project Validation Plans.
· Generation of validation protocols and final reports to cGMP standard.
· Review / approval of all protocols and final reports.
· Management of validation change control process.
· 3rd level qualification in engineering or scientific discipline.